WHITEPAPER – Monitoring Low Dose API Blend Uniformity With Parteck® M Mannitol Using Near-Infrared (NIR) Spectroscopy

Direct compression is often used for tablet manufacturing because it is the shortest, most effective, and least complex method. The physical properties of active pharmaceutical ingredients (APIs) can, however, create a challenge for flowability and compressibility, and, as a result, affect tablet quality parameters.

Segregation is one of the critical issues for low dose actives in direct compression formulations. It occurs when one component of a particulate mixture separates from the other component(s) due to differences in their physical attributes (e.g., size, shape, surface properties, cohesion) and can be induced by gravity, vibration and/or shear, all of which occur during the tableting process.1 Segregation can lead to variation in content uniformity, which in turn may result in a failure to meet product specifications1 set by various pharmacopeias. The shape and distribution of particle size of excipients are therefore important to achieve the desired blend uniformity and homogeneity. The
flowability and compressibility of excipients are also critical considerations when using direct compression to manufacture tablets.

This whitepaper describes the use of near-infrared (NIR) spectroscopy for the quantitative analysis of apixaban using Parteck® M excipient as a diluent.